Computing systems and methods for electronically indicating the acceptability of a product

ABSTRACT

Computing systems and methods for electronically indicating the acceptability of a product. An image capture and communication device may analyze a product label that includes one or more monitors, authentication elements, and identification elements. The image capture and communication device may determine the type and features of the monitors, authentication elements, and identification elements and, based on the type of the monitors, authentication elements, and identification elements. The image capture and communication device may transmit data based on the type and features to a host server, which may transmit data associated with the host product to the image capture and communication device in, inter alia, the form of an acceptability report.

FIELD OF THE INVENTION

The present invention relates to computing systems and methods forelectronically indicating the acceptability of a product.

BACKGROUND OF THE INVENTION

Medical and health care products are usually marked with a “shelf lifeexpiration” or “use by” date to enable medical practitioners, healthcareworkers, patients and the public to determine whether or not to use amedical or healthcare product. The expiration date is generally markedprominently displayed on the product label. The label may also contain avariety of additional information, including product name, manufacturername, location and date of manufactures, lot/batch number, and storageconditions. Meats, fish and other food products obtainable at asupermarket are usually marked with a “sell by” or “use by” date to helpcustomers to consume or otherwise use the food products while it isstill acceptably fresh. In the case of fresh or frozen meats and fish,the “sell by” or “use by” date is generally marked on a label which isprominently displayed on the product. The label can also contain avariety of additional information, including a product description,price information, weight information, and nutritional information.Other perishable products including various personal care products, andindustrial products can also bear a “use by” date.

Monitors are devices used to track the exposure of a host product to oneor more particular conditions, such as, temperature. Monitors, such asenvironmental monitors, may be calibrated to indicate the presence ofcertain environmental conditions, or when certain environmentalconditions surpass pre-set limits. Some monitors provide a visual orelectronic signal to make such indications.

Use of monitors in product labels can give consumers, patients or otherend users some assurance that a given product is acceptable for use byproviding some degree of protection against using products that may beineffective or spoiled because of aging or adverse conditions.

Other factors can also detract from the acceptability of commercialproducts. For example, a product may be counterfeit and have little orno acceptability. Some measures taken to prevent or identify counterfeitproducts include various track-and-trace methods which can trace themovement of a product from its manufacturer or other legitimate sourceto a consumer or other user to assure authenticity. Radio-frequencyidentification (RFID) and barcodes are two technology methods which canbe used to help implement traceability. RFID devices can be incorporatedin packages, package labeling, or other product labeling.

Regulatory agencies in the United States and elsewhere haveimplemented—or are contemplating implementing—“pedigree” requirementsfor pharmaceutical products. A pedigree is, for example, a certifiedrecord that contains information about each distribution of aprescription drug which can be electronically embodied in what is knownas an “epedigree”.

SUMMARY OF THE INVENTION

In certain embodiments, the present invention may provide a methodcomprising analyzing by an image capture and communication device aproduct label for a host product, the product label comprising at leasttwo of one or more environmental monitors, one or more authenticationelements, and one or more identification elements, determining by theimage capture and communication device a type and one or more featuresbased on the type for each of the at least two of the one or moreenvironmental monitors, one or more authentication elements, and one ormore identification elements, accessing by the image capture andcommunication device a host server, transmitting by the image captureand communication device to the host server data based on the type andfeatures for each of the at least two of the one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements, receiving by the image capture andcommunication device from the host server an acceptability report basedon the data for the at least two of the one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements, and outputting by the image capture andcommunication device the acceptability report.

In another embodiment, the present invention may provide a methodcomprising receiving by a host server one or more messages from one ormore image capture and communication devices, the one or more messagesincluding one or more acceptability for use data having authenticity,product identity, and current environmental data for one or more hostproducts, determining by the host server whether the host server hasaccess to at least one environmental history for each of the one or morehost products, tabulating by the host server one or more second messagesincluding one or more second acceptability for use data for the one ormore host products, wherein the one or more second acceptability for usedata is tabulated based on the acceptability for use data and, if thehost server has access to at least one environmental history for each ofthe one or more host products, the at least one environmental historyfoe each of the one or more host products, and transmitting by the hostserver to the one or more image capture and communication devices theone or more second messages.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and other aspects of embodiments of the present invention areexplained in the following description taken in conjunction with theaccompanying drawings, wherein:

FIG. 1 illustrates a system according to one aspect of the presentinvention;

FIG. 2A illustrates a product label 100 according to one aspect of thepresent invention;

FIG. 2B illustrates a product label 100 according to another aspect ofthe present invention;

FIG. 3 illustrates a method according to one aspect of the presentinvention;

FIG. 4 illustrates a method according to another aspect of the presentinvention;

FIG. 5 illustrates a method according to another aspect of the presentinvention;

FIG. 6A illustrates a method according to another aspect of the presentinvention;

FIG. 6B illustrates a method according to another aspect of the presentinvention;

FIG. 6C illustrates a method according to another aspect of the presentinvention;

FIG. 7A illustrates a method according to another aspect of the presentinvention;

FIG. 7B illustrates a method according to another aspect of the presentinvention; and

FIG. 7C illustrates a method according to another aspect of the presentinvention;

The drawings are exemplary, not limiting. It is intended for items thatare labeled with the same number in multiple figures to refer to thesame item throughout the figures.

DETAILED DESCRIPTION

Various embodiments of the present invention will now be described ingreater detail with reference to the drawings.

As shown in FIG. 1, one aspect of the present invention may include oneor more image capture and communication devices 170, 160 and 110directly and indirectly connected to one or more host servers 190through network 185 or cellular network 180. Host servers 190 may bedirectly or indirectly connected to one or more databases 195. Imagecapture and communication devices 170, 160, and 110 may receive datafrom one or more product labels 100.

In one aspect, an image capture and communication device may be anysingle or set of hardware equipment that is encoded and able to analyzeproduct labels 100 and transmit data collected from the analysis throughnetwork 185 or cellular network 180 to host servers 190. The imagecapture and communication device may include one or more non-transitorydata storage devices, such as harddrives, RAM, ROM, CD-ROM, DVD-ROM,floppy-disk drives, and/or solid-state memory drives; one or more inputdevices, such as a keyboard, touchpad, mouse, camera, video camera,image scanner, barcode scanner, densitometer, spectrometer, and/or RFIDreader; one or more central processing units (CPUs); one or more outputdevices, such as a display, disc drive, and/or solid-state memory drive;one or more input/output (I/O) communications ports, such as an infraredport, universal serial bus port, serial port, ethernet port, celluarport, HDMI port, Display port, modem port, Bluetooth port, and/orwireless networking controller. The hardware may be in communicationwith one another by a shared data bus and/or by dedicated connections.The image capture and communication device may have one or more memorywith at least one region for storing computer executable program codeand one or more CPUs for executing the program code stored in thememory.

The executable program code may include instructions for readingauthentication elements, monitors, and identification elements. Theexecutable program code may include instructions to store data based onthe image capture and communication device's review or communicationwith authentication elements, monitors, and identification elements. Theexecutable program code may include instructions to communicate with ahost server, transmit the data to the host server, receive data inresponse to that transmission, and generate and display a report basedon the received data. The executable program code may includeinstructions to generate a report based on the data obtained from theimage capture and communication device's review or communication withthe authentication elements, monitors, and identification elements. Theexecutable program code may include instructions to output aninterrogation signal to an RFID and to receive and/or interpret the datafrom the RFID. The executable program code may include instructions toread a one-dimensional, two-dimensional, and/or three-dimensionalbarcode to receive and/or interpret data from the barcode. Theexecutable program code may include instructions to find and recognizepatterns in a particular image. For example, the executable program codemay find a section of an image which is similar to a stored template,such as a template of a geometrical pattern, for instance, a circle.After the desired pattern is located, the pattern can be furtheranalyzed, for example, to interpret the light and dark pixels of a barcode. Such instructions may include routines from a pattern recognitionsoftware library, for example, Matrox Imaging Library, which containsroutines for image analysis and bar code reading.

In one aspect, the executable program code includes instructions tostore-and-forward data. Such an aspect may include the image capture andcommunication device's temporarily storing of data in one or morememories for transmission at a later time, for example, when the hostserver becomes available, when a network or cellular network becomesavailable, and/or when transmission price rates decrease.

The executable program code may include instructions for capturingseparate values for red, green, and blue (RGB) optical spectral rangesand converting the captured separate values into other color spaces forcomparison. For example, grayscale, which is the average of RGB value;or cyan OD, which is the negative of the logarithm to the base 10 oftheRvalue expressed as a fraction of its full-scale value.

In one aspect, the image capture and communication device 110 is amobile phone with a built-in camera and/or video camera, such as Apple'siPhone® smartphones or Research in Motion Ltd.'s BLACKBERRY®smartphones. For example, Apple's iPhone® 3G or 3Gs or Research inMotion's BLACKBERRY® Bold™ 9700 or Curve™ 8300. In another aspect, theimage capture and communication device 160 includes a computer 150connected to a camera 120. In another aspect, the image capture andcommunication device 170 includes a computer 140 connected to a camera130. Computers 140 and 150 may be a computer that generally includes oneor more data storage devices, one or more CPUs, one or more inputdevices, one or more output devices, one or more I/O communicationsports, and other hardware components that facilitate performance of thefunctions of computers 140 and 150. Computers 140 and 150 may be atablet PC; alternatively, computers 140 and 150 may be a laptopcomputer. Cameras 120 and 130 may be any camera that is directly orindirectly connected to computer 150. For example, cameras 120 and 130may be a digital camera connected via USB port or camera 120 and 130 maybe a video camera connected to computers 140 and/or 150 by removing asolid-state memory card from cameras 120 and/or 130 and placing it in asolid state memory card reader that is connected to computers 140 and/or150. Camera 120 and/or 130 may be built into or mounted on computers 140and/or 150. In another aspect, an image capture and communication devicemay include a smart phone tethered to computers 140 and/or 150. Cameras120 and/or 130 may be connected to a smart phone by removing asolid-state memory card from cameras 120 and/or 130 and placing it in asolid state memory card reader that is connected to the smart phone.

Network 185 may include any type of network infrastructure, such asclient/server, peer-to-peer, or hybrid architectures. Network 185 mayinclude the Internet. In one aspect, cellular network 180 is anycellular network. Cellular network 180 may operate under any mobiletelephony standard such as 0G, 1G, 2G, 2G transitional, 3G, 3Gtransitional, and/or 4G. Cellular network 180 may be directly orindirectly connected to network 185 and/or host servers 190.

One or more host servers 190 may be one or more remote computer systemsthat are accessible over a remote or local network or the Internet, suchas network 185, or through wireless network infrastructures, such ascellular network 180. Host servers 190 may have all of the hardwareattributes of computers 140 and 150. Host servers 190 may be distributedover two or more physical locations. Host servers 190 may include—or bedirectly or indirectly connected to—one or more databases 195. One ormore databases 195 may be any type of database, such as analytic,operational, hierarchical, network, or relational databases. Forexample, Microsoft SQL Server, MySQL, Oracle Database, Microsoft Access,Microsoft Excel file, and/or comma separated value or tab-delineatedfile. In another aspect, databases 195 may be—or include—any type ofdata structure, or nested data structures, such as tables, stacks,queues, lists, linked-lists, arrays, trees, and/or heaps.

Product label 100 may be any product or package label that has one ormore monitors, authentication elements, and/or identification elements.Product label 100 may be associated with one or more host products. Forexample, product label 100 may be placed on—or part of—the productitself, the product's packaging, or the carton, box, crate, or palletthat houses multiple products for shipping, or be stand-a-lone. Forexample, in one aspect, the product label may travel with a truck driverand be associated with one or more host products on the truck.

Examples of host products include perishable health care products, forexample vaccines, drugs, medicaments, pharmaceuticals, cosmeceuticals,nutricosmetics, nutraceuticals, and functional foods, medical devicesand prophylactics; biological materials for industrial or therapeuticuses, for example cultures, organs and other human or animal body parts,blood and perishable blood products; diagnostic devices, kits andingredients containing perishables; batteries and battery containingdevices and appliances; foodstuffs including fresh or prepared fish,meats, dairy products, fruits, vegetables, baked goods, desserts and thelike; food service products, including restaurant service foods; gourmetproducts; perishable animal foods; cut and uncut flowers; cosmetics, forexample cosmetics containing biologics or other labile ingredients;beauty aids; perishable munitions and ordnance; perishabledecontamination packs and products; and liquors, for example, wine,beer, champagne, port, whisky, cognac.

As shown in FIGS. 2A and 2B according to one aspect of the presentinvention, product label 100 may include one or more of monitors 210 and225, authentication element 230, and/or identification elements 200 and205.

The monitors may be environmental history monitors. An environmentalhistory monitor may indicate one or more conditions of the environmentalhistory of the host product which it is associated, for example, theenvironmental history monitor may indicate past exposure of the hostproduct to one or more environmental conditions. The environmentalhistory monitor's appearance may change with time to indicate thechanging value of a monitored condition.

One example of an environmental condition which can be monitored by theenvironmental history monitor is heat exposure. The environmentalhistory monitor can monitor heat exposure, either as an averagecumulative temperature or as the occurrence of a temperature eitherabove or below a specific temperature for a particular duration.Examples of such heat monitoring environmental history monitors mayinclude cumulative time-temperature indicators, freeze indicators, thawindicators and threshold indicators which can indicate a single event ofpast exposure to a temperature above ambient.

Other environmental conditions which environmental history monitors maymonitor include humidity, mechanical shock, gas exposure, oxygenexposure, toxin exposure, chemical exposure, biological agent exposure,actinic radiation exposure, x-ray exposure, and/or microwave exposure.

Product label 100 may include multiple environmental monitors, each ofwhich monitors a different environmental condition. For example, productlabel 100 may include two or more of a cumulative time-temperatureindicator, a freeze indicator, and a threshold indicator. Product label100 may include a cumulative time-temperature indicator, a freezeindicator, and a threshold indicator. Other environmental historymonitors besides, or in addition to, one or more heat exposureindicators can be included, if desired.

A monitor may include a time-temperature indicator (TTI) composed ofcolorless diacetylene monomers which develop color as they polymerize.The progressive color development occurs at a rate that increases withtemperature.

A monitor may include a multifunctional TTI which integrates twoindicator types into a single device. For instance, it may include botha primary indicator, which can develop a color change as a result ofcumulative time-temperature exposure, and a secondary indicator, whichmay be set to trigger at a predetermined temperature.

A monitor may include an activatable TTI system that includes acolor-forming time-temperature indicator system that may be affixed to aproduct label so that the indicator composition is coextensive with abarcode. Upon expiration of the useful shelf life of a host product, thecolor density may reach a level which obscures the barcode sufficientlyto register in market computer systems as a failed or unsafe product.

A monitor may include a combination RFID and environmental conditionindicator tag. Information supplied by the RFID, for example, product IDand related data, may be machine read by interrogation of the RFID at aninspection station and the visual condition indication may be opticallyread by machine at the same station. The signals can be utilized locallyat the inspection station or may be used at locations remote therefrom.Alternatively, the environmental condition indicator may have electricalproperties that may be read by the RFID device. For example, such anindicator could be one based on the etching of an aluminum film by anacid.

The solid-state polymerization of diacetylene monomers andco-precipitated monomers to polymers are useful as TTIs. The monomerscan be prepared as active agents on a substrate, or could be activatedon demand by a number of methods including solvent evaporation, meltrecrystalization, acid formation, metal formation, salt formation or theassociated removal of the acid, metal or salt.

TTIs can include an immobilized enzyme which can react with thesubstrate to produce a color change in time and temperature dependentmanner. Photo induced coloration by radiation of spiropyrans having atemperature dependent decoloration can be used as a TTI.

TTIs can include an upper layer carrying a first reactant and a baselayer carrying a second reactant adapted to react with the firstreactant upon triggering. TTIs can be formed from thermal paper and anactivating film placed on the thermal paper. An indicator can be mixedwith a portion of the food product and detects food spoilage directly,for example, pH change, through, for instance, detecting m-nitrophenol,p-nitrophenol and litmus changes from green to red/pink.

A TTI may have two surfaces that remain adhered when brought together:an acid-base indicator in one and an activator in the other. A TTI canbe based on an azo coupling reaction between a capped diazoniumcomponent and a coupling component. An enzyme based TTI including ureaseto consume urea to generate ammonia and carbon dioxide, which may causea pH change causing color change in a pH indicator.

TTIs can be prepared from a free radical-sensitive dye and peroxide on acarrier. TTIs can include a diffusion layer capable of transition abovea defined temperature. An indicator film can be placed on one side ofdiffusion layer and be separated from a reactant material capable ofproducing a color change when in contact with the indicator film.

TTIs can be produced using vapor permeation techniques. Activatable TTIcan include an oxygen-sensitive dye coating and a removable oxygenbarrier over the coating.

TTIs having a colorless leuco base and a photoacid can be activated byUV light.

TTI devices can include a substrate with organic silver salt oxidizingagent, reducing agent, and indicating indicia. TTIs can also contain aviscoelastic material, barrier material, and porous matrix.

In one aspect, the authentication element may establish or verify theauthenticity of the host product with which the monitor is associated.The authentication element may be readable by a human. For example, theauthentication element can include an area printed with a special ink, asymbol, or an object which is difficult to reproduce and which, in otheraspects, may also visually change with time. The authentication elementmay be incorporated into the identification element and/or monitor. Theidentification element may include information referencing theauthentication element. If such information, for example, fails toverify the authentication element, label 100 may indicate that the hostproduct is not authentic.

In one aspect, the identification element indicates the identity of thehost product. For example, an identification element may include aone-dimensional barcode, a two-dimensional barcode, a three dimensionalbarcode, or an RFID device. The identification element can be printedand be visible to a human and/or machine-readable. For example, theidentification element can be printed with an ink that reflectsprimarily in the near-infrared and can be read with a charge-coupleddevice (CCD) camera that is sensitive to near infrared light. Theidentification element can be accompanied by a human readable equivalentof the identification element, for example a string of text, icons,pictographs or other human-recognizable graphics or symbols.

The identification element may be unique and identifies the host productwith which it is associated. The identification element may include anitem identifier that indicates the identity of a specific individualhost product for example a stock-keeping unit.

In one aspect, the identification element may include a serial globaltrade identifier number (SGTIN). For example, a “SGTIN-96” tag. ASGTIN-96 tag data specification provides six fields that are to be setfor each tag and the combination of all six fields ensures each tag'suniqueness. The six fields are as follows: a header comprising 8 bits; afilter, comprising three bits which can specify if the tagged object isan item, case or pallet; a partition, which is three bits and indicateshow the subsequent fields are divided to get the correct data for each;a company prefix, which comprises 20-40 bits (depending on thepartition); an item reference, comprising 24-4 bits (depending on thepartition) which can comprise the item's global trade identificationnumber “GTIN”; and a serial number, which is 38 bits and contains theitem's unique serial number.

The identification element may be compatible with an e-pedigree codeused for pharmaceutical tracking. In one aspect where the identificationelement includes an RFID or other electronic device, the identificationelement may include an electrical or optical device to read the otherelements of product label 100, such as one or more monitors 210 and 225and/or authentication element 230. Monitors, such as environmentalhistory monitors, may generate both electrical and visual signalsindicating exposure to one or more environmental conditions. Suchelectrical signals may be output to an associated RFID that otherwiseacts as a identification element.

The information from monitors 210 and 225, authentication element 230,and identification elements 200 and 205 of product label 100 may beaccessible by photocapture, scanning, pattern recognition, imagecomparison, such as by using image capture and communication devices110, 160 and 170, or by human recognition.

As shown in FIG. 2A according to one aspect of the present invention,product label 100 may be configured for attachment to a case containingone or more sales units of a pharmaceutical product. Product label 100may be self-adhesive or otherwise attachable to the case. Product label100 may be printable in a single pass or in multiple passes. The entirelabel 100 may be printable. One or more monitors, authenticationelements, and/or identification elements may be separately fabricatedand then attached or applied to label 100. It is noted that productlabel 100 may include one or more monitors, authentication elements,and/or identification element that are not physically embedded orotherwise located on the same surface or housing; however, in such anaspect, the monitors, authentication elements, and/or identificationelements would be associated with the same one or more host products.

As shown in FIG. 2A according to one aspect of the present invention,label 100 may include in a header row at the top of the label,identification element 200, a two-dimensional barcode 205, and monitor210. Beneath the header row, the label has the drug name and strength,prominently displayed. Beneath the drug name appear additional data,such as, a product or list number, for example, 1 55Z5555 555 555; abatch or a lot number, for example, F 66666; an expiry date for the drugor other host product; a notation as to the case contents, for example,10 units per case; a sales unit description, for example, 2 syringes percarton; a date of manufacture of the drug; storage conditions such as apermissible range of temperature variation and a storage type, forexample, refrigerated storage; the name of the supplier; the location ofthe manufacturing plant; and the date and time of dispatch and a casenumber, for example, 72/1000. Identification element 200 may include aproduct number which may be the same as or different from theproduct/list number. The identification element 200 may be the same asor different from the product expiration date and a batch or lot number.Some or all of the information in identification element 200 may beencoded into identification element 205.

Identification element 205 can include one or more authenticationelements, for example, a serial number or a code correlated with otherinformation on label 100, which uniquely identifies the host productunit, for example, a case, and hinders counterfeiting. Authenticationelement 230 may include one or more identification elements. In anotheraspect, monitors 210 and/or 225 may include one or more identificationand/or authentication elements.

In one aspect, monitor 210 is an environmental history monitor thatoperates as a TTI. Monitor 210 may include two color zones: an activezone 220 and a reference zone 215. Active zone 220 can change color. Forexample, active zone 220's color may darken in response to cumulativetemperature exposure over time outside of acceptable limits for the hostproduct. If active zone 220 appears as dark or darker than referencezone 215, monitor 220 is indicating by visual signal that the hostproduct with which it is associated is no longer acceptable for use. Inother aspects, active zone 220's color may lighten in response tocumulative temperature exposure over time outside of acceptable limitsfor the host product. In such an aspect, if active zone 220 appearslighter than reference zone 215, monitor 220 is indicating by visualsignal that the host product with which it is associated is no longeracceptable for use. In another aspect, any suitable color value, orcombination of color values, detectable in active zone 220 and referencezone 215 may be compared, for example, grayscale reflectivity, grayscaledensity, color optical density, RGB values, Lab values, brightness, hueand/or color intensity.

As shown in FIG. 3 at step 300, in one aspect of the present invention,an image capture and communication device may analyze a product label100 (as shown in FIGS. 1, 2A, and 2B) for a host product. Based on itsanalysis, for example, by scanning for visual or electronic signalsindicative of one or more authentication elements, monitors, and/oridentification elements present on product label 100, the image captureand communication device determines a type and one or more features foreach of the one or more authentication elements, monitors, and/oridentification elements, as shown at step 305.

In one aspect, the type of an authentication element, monitor, oridentification elements indicates to the image capture and communicationdevice how the image capture and communication device may retrieve datafrom the authentication element, monitor, or identification element. Forexample, the type of an identification element may be a one-dimensionalbarcode, which may indicate to the image capture and communicationdevice to scan the barcode and interpret the barcode data. In anotherexample, the type of a monitor may be an environmental monitor with anactive zone and a reference zone, which may indicate to the imagecapture and communication device to capture an image of the two zonesfor comparison. In another example, the type of an authenticationelement may be RFID, which may indicate to the image capture andcommunication device to send an interrogation signal and retrieve thedata from the RFID.

The one or more features for each of the one or more authenticationelements, monitors, and/or identification elements are featuresassociated with the type of authentication element, monitor, andidentification element that are used to provide data stored in theauthentication element, monitor, and identification element. Forexample, if the type of identification element is a one-dimensionalbarcode, the features may be the lines and/or numbers associated withthe barcode. In another example, if the type of monitor is anenvironmental monitor that includes an active zone and a reference zone,the features of the monitor may be the color of the active zone and thecolor of the reference zone. In another example, if the type ofauthentication element is RFID, the features of the authenticationelement may be the data stored in the RFID.

As further shown in FIG. 3 at step 310 according to one aspect of thepresent invention, the image capture and communication device may accessthe one or more host servers 190 (as shown in FIG. 1). The image captureand communication device may accomplish such access by connecting tohost servers 190 through network 185 (as shown in FIG. 1) and/orcellular network 180 (as shown in FIG. 1). In other aspects, the imagecapture and communication device may connect to host servers 190 througha direct satellite link. Once the image capture and communication deviceis either directly or indirectly connected to the host server, the imagecapture and communication device may transmit the type and features foreach of one or more authentication elements, monitors, and/oridentification elements present on product label 100, as shown at step315. The image capture and communication device may transmit the typeand features to the host servers 190 (as shown in FIG. 1) via shortmessage service (SMS) text message, TCP/IP messaging, email, FTP, PINemail, and/or instant message. The image capture and communicationdevice may receive an acceptability report from host servers 190 (asshown in FIG. 1) based on the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 320. The image captureand communication device may receive the acceptability report from hostservers 190 (as shown in FIG. 1) via SMS text message, TCP/IP messaging,email, FTP, PIN email, and/or instant message. In further aspects, theimage capture and communication device may receive the acceptabilityreport from the host servers 190 (as shown in FIG. 1) by the hostservers 190 providing a uniform resource locator (URL) to a website forthe image capture and communication device to access through cellularnetwork 180 (as shown in FIG. 1) or network 185 (as shown in FIG. 1). Insuch aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

As further shown in FIG. 3 at step 325 according to one aspect of thepresent invention, the image capture and communication device maydisplay the acceptability report. For example, image capture andcommunication devices 170, 160, and/or 110 may output a text-basedand/or graphical-based acceptability report on display devices such as aliquid crystal display (LCD), light emitting diode (LED) display, orcathode ray tube (CRT) display.

The acceptability report may include text, symbols, and/or graphicsindicating any of the following: whether the host product is acceptableto use, whether the host product is authentic; product identificationdata; product history data, including the environmental history of thehost product; instructions on how the user should proceed based on thehost product's acceptability; pedigree detail, such as, a SGTIN and/orpedigree verification; and whether a new expiration or use-by date isprovided based on the environmental exposure. If the host product is apharmaceutical product, a link to download a patient information sheetmay be included. In addition, late breaking warnings as to possibleadverse reactions, product recall information, directions, or requests,or a link to such information, may also be included in the report. Theacceptability report may include a link for the holder of the hostproduct to re-order or return the host product. Such information may betriggered by data received from the one or more authentication elements,monitors, and/or identification elements.

The acceptability report may be output audibly by the image capture andcommunication device. For example, the image capture and communicationdevice may use text-to-speech routines or speech libraries located oneither the host servers or image capture and communication device. Suchaspects may help vision-impaired users understand whether a host productis acceptable to use.

As shown in FIG. 4 at step 400, according to one aspect of the presentinvention, one or more image capture and communication devices 170, 160,and 110 (as shown in FIG. 1) may analyze a monitor with a type and oneor more features based on the type for a host product. The one or moreimage capture and communication devices may take a still picture orimage of the monitor. At step 405, the one or more image capture andcommunications devices may determine the type of monitor and the one ormore features based on the type. At step 410, the one or more imagecapture and communication devices may determine whether the one or morefeatures and/or type indicate that the monitor contains a colorreference zone, which has a reference area and an active area, such asare included in monitor 210 (as shown in FIG. 2A).

If the features and/or type indicate that the monitor contains a colorreference zone, at step 415, the one or more image capture andcommunication devices may measure one or more first pixel locations ofthe reference area and one or more second pixel locations of the activearea. In one aspect, the measuring at step 415 is done through executingpattern recognition routines. At step 420, the one or more image captureand communication devices may derive a first RGB value of the referencearea based on the one or more first pixel locations and a second RGBvalue of the active area based on the one or more second pixellocations. At step 425, the one or more image capture and communicationdevices may convert the first RGB value to a first color space value andthe second RGB value to a second color space value. At step 430, the oneor more image capture and communication devices may compare the firstcolor space value to the second color space value. For example, colorspace values may be grayscale, which is obtained by calculating theaverage of the RGB values. Another color space value example may be cyanOD, which is obtained by calculating the negative of the logarithm tothe base 10 of the R value expressed as a fraction of its full-scalevalue.

At step 435, the one or more image capture and communication devices maydetermine whether, for example, the still image or picture containssufficient color resolution for the one or more image capture andcommunication devices or the one or more host servers 190 (as shown inFIG. 1) to derive color space values accurate enough to provide allavailable product information from the monitor. For instance, it ispossible that if the lighting conditions are poor and the an imagecapture or communication device may not have created enough light, theimage capture and communication device may still have retrievedsufficient data to determine whether the active zone is darker orlighter than the reference zone, but not sufficient data to accuratelydetermine the degree of darkness and lightness necessary to derive moredata from the comparison. If the one or more image capture andcommunication devices determine that the still image or picture does notcontain sufficient color resolution, at step 440, the one or more imagecapture and communication devices may determine whether, based on thatcomparison (at step 430), the host product is acceptable for use. Infurther aspects, because of the lack of sufficient color, anyacceptability data generated downstream may indicate whether the hostproduct is acceptable, but may not accurately indicate the degree ofacceptability, for example, the degree of exposure to a particularcondition. In such an aspect, the degrees of acceptability may beomitted from acceptability reports.

If the one or more image capture and communication devices determinethat the still image or picture does contain sufficient colorresolution, at step 445, the one or more image capture and communicationdevices may determine whether, based on that comparison (at step 430),the host product is acceptable for use and may indicate the degree ofacceptability of use in any acceptability report generated downstream.In one aspect if the active zone's color may darken in response tocumulative temperature exposure over time outside of acceptable limitsfor the host product. If the active zone's color is as dark or darkerthan reference zone, the monitor may be indicating by visual signal thatthe host product with which it is associated is no longer acceptable foruse. In another aspect, the active zone's color may lighten in responseto cumulative temperature exposure over time outside of acceptablelimits for the host product. In such aspects, if the active zone's coloris lighter than reference zone's color, the monitor may be indicating byvisual signal that the host product with which it is associated is nolonger acceptable for use.

If, at step 410, the one or more image capture and communication devicesdetermines that the features and/or type indicate that the monitor doesnot contain a color reference zone, at step 460, the one or more imagecapture and communication devices may measure one or more first pixellocations of the active area. In one aspect, the measuring at step 460is done through executing pattern recognition routines. At step 465, theone or more image capture and communication devices determines, based onthe type and/or features of the monitor, whether the monitor providesinformation, such as environmental condition, by color. If the monitorprovides information by color, at step 470, the one or more imagecapture and communication devices may derive a first RGB value of theactive area based on the one or more first pixel locations. At step 475,the one or more image capture and communication devices may convert thefirst RGB value to a first color space value. At step 480, the one ormore image capture and communication devices may compare the first colorspace value to a set of values based on the type and/or features of themonitor in order to determine if the color space value is less than,equal to, or greater than the set of values. Based on the comparison (atstep 480), the one or more image capture and communication devices, atstep 481, may determine whether the host product is acceptable for use.

If the monitor does not provide information by color, at step 485, theone or more image capture and communication devices determines whetherinformation is provided by determining a particular visual pattern onthe monitor. For example, in one aspect, if certain environmentalconditions are present, a symbol may appear in the active area, such asa check mark as shown in monitor 225 in FIG. 2A. At step 486, if thevisual pattern is present on the monitor, the one or more image captureand communication devices may determine, based on the visual pattern,whether the host product is acceptable for use. Depending on the typeand features of the monitor, the existence of a visual pattern mayindicate that a host product is or is not acceptable for use; or, thevisual pattern may need to be interpreted in light of other data, suchas other data from other monitors, authentication elements, and/oridentity elements, in order for the image capture and communicationdevice and/or host servers to determine whether the host product isacceptable for use.

At step 450, the one or more image capture and communication devicesdetermines whether the image capture and communication device isdirectly or indirectly connected to one or more host servers 190 (asshown in FIG. 1) through network 185 (as shown in FIG. 1). If the one ormore image capture and communication devices determines that it isconnected to one or more host servers through network 185, the imagecapture and communication device may, at step 490, transmit dataincluding the type, features, comparison results (at steps 430 and/or480), and/or determination results (at steps 435, 440, 481, and/or 486)to the one or more host servers. At step 492, the image capture andcommunication device may receive data from the host server that isassociated with the one or more host product that is associated with themonitor and output the data in the form of an acceptability report (asdescribed in step 325 in FIG. 3). Such data may include the hostproduct's name, strength, presentation (for example, pre-filled syringe,vial, ampoule, etc.), quantity, product identification number,serialized numeric identifier (SNI), SGTIN, numeric drug code (NDC), lotnumber, expiration date, location of manufacture, date of manufacture,storage conditions, date/time and condition of unit from each readingincluding identification, authentication and monitor, site of reading orGPS information, identity of reading device or person or entity makingthe reading, product specific information (for example, specifications,package insert, use instructions, etc.), recall status, warrantyinformation, product coupons for discounts, notice of product statuschange (for example, if the product is subject to a recall or otheraction, notice could be automatically sent to the last entity readingthe acceptability device), notice to reorder product, information andemergency call or e-mail addresses.

If the one or more image capture and communication devices determinethat it is not connected to one or more host servers through network185, at step 451, the one or more image capture and communicationdevices determine whether they can transmit a message, such as SMS,through cellular network 180 to the one or more host servers. If the oneor more image capture and communication devices determine that they cantransmit a message, at step 495, the one or more image capture andcommunication devices may receive data from the host server that isassociated with the one or more host products that are associated withthe monitor. In one aspect, the data may be in the form of a link, suchas a URL, that references a webpage that hosts an acceptability reportthat the one or more host servers have generated (as described in step325 in FIG. 3).

If the one or more image capture and communication devices determinethat they cannot transmit a message, at step 455, the one or more imagecapture and communication devices may output to the user anacceptability report based on the results of the comparisons anddeterminations at steps 430, 435, 440, 480, 481, and/or 486. The outputmay be in the form of a visual display and/or audible display.

As shown in FIG. 5 at step 500, in one aspect of the present invention,one or more host servers 190 (as shown in FIG. 1) may receive a messageor other data from one or more image capture and communication devices170, 160, and 110 (as shown in FIG. 1) including the type and featuresof each of the one or more authentication elements, monitors, and/oridentification elements present on the product label that the imagecapture and communication device 170, 160, and 110 analyzes. In furtheraspects, message or data is received via SMS text message, TCP/IPmessaging, email, FTP, PIN email, and/or instant message.

As further shown in FIG. 5 at step 505, based on the message or data,the host servers 190 (as shown in FIG. 1) retrieve information about thehost product from one or more databases 195 (as shown in FIG. 1) andstore the message or data that was received from the image capture andcommunication device 170, 160, and 110 (as shown in FIG. 1) in databases195. Information about the host product may include the host product'sname, strength, presentation (for example, pre-filled syringe, vial,ampoule, etc.), quantity, product identification number, SNI, SGTIN,NDC, lot number, expiration date, location of manufacture, date ofmanufacture, storage conditions, date/time and condition of unit fromeach reading including identification, authentication and monitor, siteof reading or GPS information, identity of reading device or person orentity making the reading, product specific information (for example,specifications, package insert, use instructions, etc.), recall status,warranty information, product coupons for discounts, notice of productstatus change (for example, if the product is subject to a recall orother action, notice could be automatically sent to the last entityreading the acceptability device), notice to reorder product,information and emergency call or e-mail addresses.

In further aspects, at step 510, based on the message or data, the hostserver 190 (as shown in FIG. 1) may determine, for example, whether thehost product is authentic and/or whether the host product was exposed toenvironmental conditions outside or inside set limits for the hostproduct. At step 515 one or more host servers 190 (as shown in FIG. 1)may store information referencing the determination (made at step 510)in the one or more databases 195 (as shown in FIG. 1) 515. At step 520,host servers 190 (as shown in FIG. 1) may generate an acceptabilityreport based on the determination (made at step 510). In one aspect,generating an acceptability report (generated at step 520) may includegenerating an HTML-based webpage and a URL pointing to the webpage. Atstep 525, the host servers 190 (as shown in FIG. 1) may transmit amessage or data including the URL to the image capture and communicationdevice via cellular network 180 (as shown in FIG. 1) or network 185 (asshown in FIG. 1).

In another aspect, generating an acceptability report (generated at step520) may include tabulating data based on the determination (made atstep 510) and/or other attributes of the host product. In such anaspect, at step 525, one or more host servers 190 (as shown in FIG. 1)may transmit the acceptability report in the form of such tabulated datato the image capture and communication device 170, 160, and/or 110 (asshown in FIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PINemail, and/or instant message.

As shown in FIGS. 6A, 6B, and 6C, according to one aspect of the presentinvention a manufacturer of a host product may use systems and methodsof the present invention to track the acceptability of the host productthroughout the steps of clinical trials of the host product. Forexample, at step 600, the manufacturer may associate one or more hostproducts with a product label 100 (as shown in FIGS. 1., 2A, and 2B)including at least two of one or more monitors, product identificationelements, and authentication elements. During the association (at step600), the manufacturer may set the limits or other data for each of theone or more monitors, product identification elements, and/orauthentication elements; or, the manufacturer may use one or moremonitors, product identification elements, and/or authenticationelements with pre-set limits and/or data as appropriate for theparticular host product.

At step 604, before the manufacturer is ready to release the product foruse at a clinical trial, an image capture and communication device mayanalyze a product label 100 (as shown in FIGS. 1, 2A, and 2B) for a hostproduct at the host product's site of manufacture. Based on itsanalysis, for example, by scanning for visual or electronic signalsindicative of one or more authentication elements, monitors, and/oridentification elements present on product label 100, the image captureand communication device determines a type and one or more features foreach of the one or more authentication elements, monitors, and/oridentification elements, as shown at step 605.

At step 610, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). The image capture andcommunication device may accomplish such access by connecting to hostservers 190 through network 185 (as shown in FIG. 1) and/or cellularnetwork 180 (as shown in FIG. 1). In other aspects, the image captureand communication device may connect to host servers 190 through adirect satellite link. Once the image capture and communication deviceis either directly or indirectly connected to the host server, the imagecapture and communication device may transmit the type and features foreach of one or more authentication elements, monitors, and/oridentification elements present on product label 100, as shown at step615. The image capture and communication device may transmit the typeand features to the host servers 190 (as shown in FIG. 1) via shortmessage service (SMS) text message, TCP/IP messaging, email, FTP, PINemail, and/or instant message. The image capture and communicationdevice may receive an acceptability report from host servers 190 (asshown in FIG. 1) based on the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 620. The image captureand communication device may receive the acceptability report from hostservers 190 (as shown in FIG. 1) via SMS text message, TCP/IP messaging,email, FTP, PIN email, and/or instant message. In further aspects, theimage capture and communication device may receive the acceptabilityreport from the host servers 190 (as shown in FIG. 1) by the hostservers 190 providing a uniform resource locator (URL) to a website forthe image capture and communication device to access through cellularnetwork 180 (as shown in FIG. 1) or network 185 (as shown in FIG. 1). Insuch aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

At step 625 according to one aspect of the present invention, the imagecapture and communication device may output the acceptability report.For example, image capture and communication devices 170, 160, and/or110 may output a text-based and/or graphical-based acceptability reporton display devices such as a LCD display, LED display, or CRT display.In addition, an audible report may be output in lieu of—or in additionto—the graphically displayed report. At step 630, based on the outputtedacceptability report, either the user of the image capture andcommunication device—or the device itself—may determine whether the hostproduct is acceptable for use. For example, the acceptability report mayactually state “it is not acceptable for use” or “it is acceptable use”or provide certain data for interpretation by its user or thedevice/host servers itself/themselves. At step 634, if the host productis not acceptable for use, it may not be shipped out. In a furtheraspect, the acceptability report may include instructions transmitted orgenerated by the manufacturer about what the user should do with anunacceptable product. If the product is acceptable for use, at step 635,the host product is released to a clinic, such as a hospital.

At step 640, the clinic and/or delivery driver may analyze the inboundproduct label 100 (as shown in FIGS. 1, 2A, and 2B) of the host productat the clinic. Based on its analysis, the image capture andcommunication device determines a type and one or more features for eachof the one or more authentication elements, monitors, and/oridentification elements, as shown at step 645.

At step 650, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 655. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 660. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture. The image capture and communication device mayreceive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 665, the image capture and communication device may output theacceptability report. At step 670, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 671, if the host product is not acceptable for use, itmay not be shipped out and returned to the manufacturer. In a furtheraspect, the acceptability report may include instructions transmitted orgenerated by the manufacturer about what the clinic should do with anunacceptable product. If the product is acceptable for use, at step 675,the host product may be stored until such time as the clinic decides torelease the host product to a patient or practitioner.

At step 680, the clinic may analyze the product label 100 (as shown inFIGS. 1, 2A, and 2B) of the stored host product at the clinic. Based onits analysis, the image capture and communication device determines atype and one or more features for each of the one or more authenticationelements, monitors, and/or identification elements, as shown at step685.

At step 690, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 695. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 700. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture and inbound at the clinic. The image capture andcommunication device may receive the acceptability report from hostservers 190 (as shown in FIG. 1) via SMS text message, TCP/IP messaging,email, FTP, PIN email, and/or instant message. In further aspects, theimage capture and communication device may receive the acceptabilityreport from the host servers 190 (as shown in FIG. 1) by the hostservers 190 providing a uniform resource locator (URL) to a website forthe image capture and communication device to access through cellularnetwork 180 (as shown in FIG. 1) or network 185 (as shown in FIG. 1). Insuch aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

At step 705, the image capture and communication device may output theacceptability report. At step 710, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 711, if the host product is not acceptable for use, itmay not be distributed to a patient or practitioner for use in the trialand is returned to the manufacturer. In a further aspect, theacceptability report may include instructions transmitted or generatedby the manufacturer about what the clinic should do with an unacceptableproduct. If the product is acceptable for use, at step 715, the hostproduct may be distributed to a patient or practitioner.

At step 720, the patient or practitioner may analyze the product label100 (as shown in FIGS. 1, 2A, and 2B) of the host product at thepractitioner's office, patient's home, or other place where the hostproduct is administered to the patient. Based on its analysis, the imagecapture and communication device determines a type and one or morefeatures for each of the one or more authentication elements, monitors,and/or identification elements, as shown at step 725.

At step 730, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 735. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 740. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture and inbound and outbound at the clinic. The imagecapture and communication device may receive the acceptability reportfrom host servers 190 (as shown in FIG. 1) via SMS text message, TCP/IPmessaging, email, FTP, PIN email, and/or instant message. In furtheraspects, the image capture and communication device may receive theacceptability report from the host servers 190 (as shown in FIG. 1) bythe host servers 190 providing a uniform resource locator (URL) to awebsite for the image capture and communication device to access throughcellular network 180 (as shown in FIG. 1) or network 185 (as shown inFIG. 1). In such aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

At step 745, the image capture and communication device may output theacceptability report. At step 750, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 751, if the host product is not acceptable for use, itmay not be used or caused to be used by a patient or practitioner in thetrial and is returned to the manufacturer. In a further aspect, theacceptability report may include instructions transmitted or generatedby the manufacturer about what the clinic should do with an unacceptableproduct. If the product is acceptable for use, at step 755, the hostproduct may be used—or caused to be used—by a patient or practitioner.

At step 760, the patient or practitioner may withdraw from the clinicaltrial and return the host product to the clinic. On the host product'sreturn, the clinic may analyze the product label 100 (as shown in FIGS.1, 2A, and 2B) of the host product. Based on its analysis, the imagecapture and communication device determines a type and one or morefeatures for each of the one or more authentication elements, monitors,and/or identification elements, as shown at step 765.

At step 770, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 775. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 780. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture, inbound and outbound at the clinic, and at thepractitioner's office, patient's home, and/or other place the hostproduct was administered to the patient. In a further aspect, any datacollected by any image capture and communication devices from productlabel 100 may be taken into account as historical information for theproduct acceptability report. The image capture and communication devicemay receive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 785, the image capture and communication device may output theacceptability report. At step 795, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 796, if the host product is not acceptable for use, itmay not be re-used and thus cannot be redistributed by the clinic ormanufacturer and may be returned to the manufacturer for destruction. Ina further aspect, the acceptability report may include instructionstransmitted or generated by the manufacturer about what the clinicshould do with an unacceptable product. If the product is acceptable foruse, at step 800, the host product may be returned to the manufacturerfor restocking and/or repackaging. In a further aspect, theacceptability report may include instructions transmitted or generatedby the manufacturer about what the clinic should do with an acceptableproduct.

At step 805, on the host product's return, the manufacturer may analyzethe product label 100 (as shown in FIGS. 1, 2A, and 2B) of the hostproduct. Based on its analysis, the image capture and communicationdevice determines a type and one or more features for each of the one ormore authentication elements, monitors, and/or identification elements,as shown at step 810.

At step 815, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 820. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 825. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture, inbound and outbound at the clinic, and at thepractitioner's office, patient's home, and/or other place the hostproduct was administered to the patient. In a further aspect, any datacollected by any image capture and communication devices from productlabel 100 may be taken into account as historical information for theproduct acceptability report. The image capture and communication devicemay receive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 830, the image capture and communication device may output theacceptability report. At step 835, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 836, if the host product is not acceptable for use, itmay not be re-stocked or repackaged and may be sent for destruction. Ina further aspect, the acceptability report may include instructionstransmitted or generated by the manufacturer about what the manufacturershould do with an unacceptable product. If the product is acceptable foruse, at step 840, the host product may be restocked, repackaged, and/orre-issued to a clinic and/or patient or practitioner

In steps 600-840, the one or more image capture and communicationdevices may be the same image capture and communication devices,different image capture and communication devices, or the same devicefor some steps and different devices for other steps.

As shown in FIGS. 7A, 7B, and 7C, according to one aspect of the presentinvention a manufacturer of a host product may use systems and methodsof the present invention to track the acceptability of the host productthroughout the steps of its supply or distribution chain for the hostproduct. For example, at step 900, the manufacturer may associate one ormore host products with a product label 100 (as shown in FIGS. 1., 2A,and 2B) including at least two of one or more monitors, productidentification elements, and authentication elements. During theassociation (at step 900), the manufacturer may set the limits or otherdata for each of the one or more monitors, product identificationelements, and/or authentication elements; or, the manufacturer may useone or more monitors, product identification elements, and/orauthentication elements with pre-set limits and/or data as appropriatefor the particular host product.

At step 904, before the manufacturer is ready to release the product fordistribution through its supply chain, an image capture andcommunication device may analyze a product label 100 (as shown in FIGS.1, 2A, and 2B) of a host product at the host product's site ofmanufacture. Based on its analysis, for example, by scanning for visualor electronic signals indicative of one or more authentication elements,monitors, and/or identification elements present on product label 100,the image capture and communication device determines a type and one ormore features for each of the one or more authentication elements,monitors, and/or identification elements, as shown at step 905.

At step 910, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). The image capture andcommunication device may accomplish such access by connecting to hostservers 190 through network 185 (as shown in FIG. 1) and/or cellularnetwork 180 (as shown in FIG. 1). In other aspects, the image captureand communication device may connect to host servers 190 through adirect satellite link. Once the image capture and communication deviceis either directly or indirectly connected to the host server, the imagecapture and communication device may transmit the type and features foreach of one or more authentication elements, monitors, and/oridentification elements present on product label 100, as shown at step915. The image capture and communication device may transmit the typeand features to the host servers 190 (as shown in FIG. 1) via shortmessage service (SMS) text message, TCP/IP messaging, email, FTP, PINemail, and/or instant message. The image capture and communicationdevice may receive an acceptability report from host servers 190 (asshown in FIG. 1) based on the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 920. The image captureand communication device may receive the acceptability report from hostservers 190 (as shown in FIG. 1) via SMS text message, TCP/IP messaging,email, FTP, PIN email, and/or instant message. In further aspects, theimage capture and communication device may receive the acceptabilityreport from the host servers 190 (as shown in FIG. 1) by the hostservers 190 providing a uniform resource locator (URL) to a website forthe image capture and communication device to access through cellularnetwork 180 (as shown in FIG. 1) or network 185 (as shown in FIG. 1). Insuch aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

At step 925, according to one aspect of the present invention, the imagecapture and communication device may output the acceptability report.For example, image capture and communication devices 170, 160, and/or110 may output a text-based and/or graphical-based acceptability reporton display devices such as a LCD display, LED display, or CRT display.In addition, an audible report may be output in lieu of—or in additionto—the graphically displayed report. At step 930, based on the outputtedacceptability report, either the user of the image capture andcommunication device—or the device itself—may determine whether the hostproduct is acceptable for use. For example, the acceptability report mayactually state “it is not acceptable for distribution” or “it isacceptable distribution” or provide certain data for interpretation byits user or the device/host servers itself/themselves. At step 931, ifthe host product is not acceptable for use, it may not be shipped out.In a further aspect, the acceptability report may include instructionstransmitted or generated by the manufacturer about what the user shoulddo with an unacceptable product. If the product is acceptable for use,at step 935, the host product is released to a supply chain intermediaryuser, such as a distributor or wholesaler.

At step 940, the clinic and/or delivery driver may analyze the inboundproduct label 100 (as shown in FIGS. 1, 2A, and 2B) of the host productat the clinic. Based on its analysis, the image capture andcommunication device determines a type and one or more features for eachof the one or more authentication elements, monitors, and/oridentification elements, as shown at step 945.

At step 950, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 955. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 960. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture. The image capture and communication device mayreceive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 965, the image capture and communication device may output theacceptability report. At step 970, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 971, if the host product is not acceptable for use, itmay cease the supply chain process (for example, not further distributethe host product) and return it to the manufacturer. In a furtheraspect, the acceptability report may include instructions transmitted orgenerated by the manufacturer about what the supply chain intermediaryuser should do with an unacceptable product. If the product isacceptable for use, at step 975, the host product may be stored untilsuch time as the supply chain intermediary user decides to release thehost product to an end-user.

At step 980, the supply chain intermediary user may analyze the productlabel 100 (as shown in FIGS. 1, 2A, and 2B) of the stored host product.Based on its analysis, the image capture and communication devicedetermines a type and one or more features for each of the one or moreauthentication elements, monitors, and/or identification elements, asshown at step 985.

At step 990, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 995. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 1000. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture and inbound at the supply chain intermediary user.The image capture and communication device may receive the acceptabilityreport from host servers 190 (as shown in FIG. 1) via SMS text message,TCP/IP messaging, email, FTP, PIN email, and/or instant message. Infurther aspects, the image capture and communication device may receivethe acceptability report from the host servers 190 (as shown in FIG. 1)by the host servers 190 providing a uniform resource locator (URL) to awebsite for the image capture and communication device to access throughcellular network 180 (as shown in FIG. 1) or network 185 (as shown inFIG. 1). In such aspects, host servers 190 (as shown in FIG. 1) post theacceptability report to the website available at the URL.

At step 1005, the image capture and communication device may output theacceptability report. At step 1010, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 1011, if the host product is not acceptable for use, itmay not be distributed to an end-user and is returned to themanufacturer. In a further aspect, the acceptability report may includeinstructions transmitted or generated by the manufacturer about what thesupply chain intermediary user should do with an unacceptable product.If the product is acceptable for use, at step 1015, the host product maybe distributed to an end-user.

At step 1020, the end-user may analyze the product label 100 (as shownin FIGS. 1, 2A, and 2B) of the host product. Based on its analysis, theimage capture and communication device determines a type and one or morefeatures for each of the one or more authentication elements, monitors,and/or identification elements, as shown at step 1025.

At step 1030, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 1035. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 1040. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture and inbound and outbound at the supply chainintermediary user's location. The image capture and communication devicemay receive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 1045, the image capture and communication device may output theacceptability report. At step 1050, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 1051, if the host product is not acceptable for use, itmay not be used or caused to be used by the end-user and is returned tothe manufacturer directly or indirectly through the supply chainintermediary user. In a further aspect, the acceptability report mayinclude instructions transmitted or generated by the manufacturer aboutwhat the end-user should do with an unacceptable product. If the productis acceptable for use, at step 1055, the host product may be used—orcaused to be used—by the end-user.

At step 1060, the end-user may decide to return the host product to thesupply chain intermediary user or the manufacturer. On the host productsreturn to the supply chain intermediary user, the supply chainintermediary user may analyze the product label 100 (as shown in FIGS.1, 2A, and 2B) of the host product. Based on its analysis, the imagecapture and communication device determines a type and one or morefeatures for each of the one or more authentication elements, monitors,and/or identification elements, as shown at step 1065.

At step 1070, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 1075. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 1080. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture, inbound and outbound at the supply chainintermediary user's location, and at the end-user's location or place itused the host product. In a further aspect, any data collected by anyimage capture and communication devices from product label 100 may betaken into account as historical information for the productacceptability report. The image capture and communication device mayreceive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 1085, the image capture and communication device may output theacceptability report. At step 1090, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 1091, if the host product is not acceptable for use, itmay not be re-used and thus cannot be redistributed by the clinic ormanufacturer and may be returned to the manufacturer for destruction. Ina further aspect, the acceptability report may include instructionstransmitted or generated by the manufacturer about what the supply chainintermediary user should do with an unacceptable product. If the productis acceptable for use, at step 1095, the host product may be returned tothe manufacturer for restocking and/or repackaging. In a further aspect,the acceptability report may include instructions transmitted orgenerated by the manufacturer about what the supply chain intermediaryuser should do with an acceptable product.

At step 1100, on the host product's return, the manufacturer may analyzethe product label 100 (as shown in FIGS. 1, 2A, and 2B) of the hostproduct. Based on its analysis, the image capture and communicationdevice determines a type and one or more features for each of the one ormore authentication elements, monitors, and/or identification elements,as shown at step 1105.

At step 1110, the image capture and communication device may access theone or more host servers 190 (as shown in FIG. 1). Once the imagecapture and communication device is either directly or indirectlyconnected to the host server, the image capture and communication devicemay transmit the type and features for each of one or moreauthentication elements, monitors, and/or identification elementspresent on product label 100, as shown at step 1115. The image captureand communication device may receive an acceptability report from hostservers 190 (as shown in FIG. 1) based on the type and features for eachof one or more authentication elements, monitors, and/or identificationelements present on product label 100, as shown at step 1120. Inaddition, the acceptability report may also take into account historicalinformation about the host product, including the data collected at thesite of manufacture, inbound and outbound at the supply chainintermediary user's location, and at the end-user location or place theend-user used the host product. In a further aspect, any data collectedby any image capture and communication devices from product label 100may be taken into account as historical information for the productacceptability report. The image capture and communication device mayreceive the acceptability report from host servers 190 (as shown inFIG. 1) via SMS text message, TCP/IP messaging, email, FTP, PIN email,and/or instant message. In further aspects, the image capture andcommunication device may receive the acceptability report from the hostservers 190 (as shown in FIG. 1) by the host servers 190 providing auniform resource locator (URL) to a website for the image capture andcommunication device to access through cellular network 180 (as shown inFIG. 1) or network 185 (as shown in FIG. 1). In such aspects, hostservers 190 (as shown in FIG. 1) post the acceptability report to thewebsite available at the URL.

At step 1125, the image capture and communication device may output theacceptability report. At step 1130, based on the outputted acceptabilityreport, either the user of the image capture and communication device—orthe device itself—may determine whether the host product is acceptablefor use. At step 1131, if the host product is not acceptable for use, itmay not be re-stocked or repackaged and may be sent for destruction. Ina further aspect, the acceptability report may include instructionstransmitted or generated by the manufacturer about what the manufacturershould do with an unacceptable product. If the product is acceptable foruse, at step 1135, the host product may be restocked, repackaged, and/orre-issued to a supply chain intermediary user and/or end-user.

In steps 900-1135, the one or more image capture and communicationdevices may be the same image capture and communication devices,different image capture and communication devices, or the same devicefor some steps and different devices for other steps.

Although illustrative embodiments have been shown and described hereinin detail, it should be noted and will be appreciated by those skilledin the art that there may be numerous variations and other embodimentsthat may be equivalent to those explicitly shown and described. Forexample, the scope of the present invention is not necessarily limitedin all cases to execution of the aforementioned steps in the orderdiscussed. Unless otherwise specifically stated, terms and expressionshave been used herein as terms of description, not of limitation.Accordingly, the invention is not to be limited by the specificillustrated and described embodiments (or the terms or expressions usedto describe them) but only by the scope of claims.

1-16. (canceled)
 17. A method comprising: (a) analyzing by an imagecapture and communication device a product label for a host product, theproduct label comprising at least two of one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements; (b) determining by the image capture andcommunication device a type and one or more features based on the typefor each of the at least two of the one or more environmental monitors,one or more authentication elements, and one or more identificationelements; (c) tabulating by the image capture and communication devicedata based on the type and features for each of the at least two of theone or more environmental monitors, one or more authentication elements,and one or more identification elements; (e) generating by the imagecapture and communication device from the host server an acceptabilityreport based on the data for the at least two of the one or moreenvironmental monitors, one or more authentication elements, and one ormore identification elements; and (f) outputting by the image captureand communication device the acceptability report.
 18. Acomputer-readable non-transitory storage medium having computerexecutable software code stored thereon, the code for matching orders,the code comprising: (a) code for analyzing by an image capture andcommunication device a product label for a host product, the productlabel comprising at least two of one or more environmental monitors, oneor more authentication elements, and one or more identificationelements; (b) code for determining by the image capture andcommunication device a type and one or more features based on the typefor each of the at least two of the one or more environmental monitors,one or more authentication elements, and one or more identificationelements; (c) code for tabulating by the image capture and communicationdevice data based on the type and features for each of the at least twoof the one or more environmental monitors, one or more authenticationelements, and one or more identification elements; (e) code forgenerating by the image capture and communication device from the hostserver an acceptability report based on the data for the at least two ofthe one or more environmental monitors, one or more authenticationelements, and one or more identification elements; and (f) code foroutputting by the image capture and communication device theacceptability report.
 19. A method comprising: (a) analyzing by an imagecapture and communication device a product label for a host product, theproduct label comprising at least two of one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements; (b) determining by the image capture andcommunication device a type and one or more features based on the typefor each of the at least two of the one or more environmental monitors,one or more authentication elements, and one or more identificationelements; (c) determining by the image capture and communication devicewhether a host server is available; (d) responsive to determining thatthe host server is not available: (d)(i) storing in the image captureand communication device data based on the type and features for each ofthe at least two of the one or more environmental monitors, one or moreauthentication elements, and one or more identification elements;(d)(ii) determining by the image capture and communication devicewhether the host server is available (e) responsive to determining thatthe host server is available: (e)(i) accessing by the image capture andcommunication device the host server; (e)(ii) transmitting by the imagecapture and communication device to the host server the data; (e)(iii)receiving by the image capture and communication device from the hostserver an acceptability report based on the data for the at least two ofthe one or more environmental monitors, one or more authenticationelements, and one or more identification elements; and (e)(iv)outputting by the image capture and communication device theacceptability report.
 20. A programmed computer system comprising: (a)at least one memory having at least one region for storing computerexecutable program code; and (b) at least one processor for executingthe program code stored in the memory, wherein the program code, whenexecuted: (b)(i) analyzes a product label for a host product, theproduct label comprising at least two of one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements; (b)(ii) determines a type and one or morefeatures based on the type for each of the at least two of the one ormore environmental monitors, one or more authentication elements, andone or more identification elements; (b)(iii) determines whether a hostserver is available; (b)(iv) responsive to determining that the hostserver is not available: (b)(iv)(a) stores data in a non-transitorycomputer-readable storage medium based on the type and features for eachof the at least two of the one or more environmental monitors, one ormore authentication elements, and one or more identification elements;(b)(iv)(b) determines whether the host server is available (b)(v)responsive to determining that the host server is available: (b)(v)(a)accesses the host server; (b)(v)(b) transmits to the host server thedata; (b)(v)(c) receives from the host server an acceptability reportbased on the data for the at least two of the one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements; and (b)(v)(d) outputs the acceptability report.21-23. (canceled)
 24. A method comprising: (a) receiving by a hostserver one or more messages from one or more image capture andcommunication devices, the one or more messages including one or moreacceptability for use data having authenticity, product identity, andcurrent environmental data for one or more host products; (b)determining by the host server whether the host server has access to atleast one environmental history for each of the one or more hostproducts; (c) tabulating by the host server one or more second messagesincluding one or more second acceptability for use data for the one ormore host products, wherein the one or more second acceptability for usedata is tabulated based on the acceptability for use data and, if thehost server has access to at least one environmental history for each ofthe one or more host products, the at least one environmental historyfoe each of the one or more host products; and (d) transmitting by thehost server to the one or more image capture and communication devicesthe one or more second messages.
 25. A method comprising: (a) receivingby a host server data associated with a host product from an imagecapture and communication device's reading of a product label of thehost product, the data comprising an authentication element data and anenvironmental history monitor data; (b) storing the data in anon-transitory computer readable storage medium; (c) receiving by thehost server a second data associated with the host product from a secondimage capture and communication device's reading of the label of thehost product, the second data comprising an updated authenticationelement data and an updated environmental history monitor data; (d)storing the second data in the non-transitory computer readable storagemedium; (e) determining by the host server whether the host product isacceptable for use based on the authentication element data,environmental history monitor data, updated authentication element data,and updated environmental history monitor data; and (f) transmitting bythe host server to the second image capture and communication device athird data indicating whether the host product is acceptable to use. 26.A method of re-using a host product from a patient or practitioner thatwithdrew from a clinical trial, the method comprising: (a) receiving bya host server data associated with the host product from an imagecapture and communication device's one or more readings of a productlabel of the host product throughout the host product's distribution inthe clinical trial, the data comprising product identification, productauthentication, and environmental history monitor information; (b)storing the data in a non-transitory computer readable storage medium;(c) determining by the host server whether the host product isacceptable for use by a clinic or a second patient or practitioner basedon the product identification, product authentication, and environmentalhistory information; and (d) transmitting by the host server to theimage capture and communication device an acceptability report.
 27. Amethod of re-using a host product from an end-user in a supply chainthat returned the host product, the method comprising: (a) receiving bya host server data associated with the host product from an imagecapture and communication device's one or more readings of a productlabel of the host product throughout the host product's distribution inthe supply chain, the data comprising product identification, productauthentication, and environmental history monitor information; (b)storing the data in a non-transitory computer readable storage medium;(c) determining by the host server whether the host product isacceptable for use by a second end-user based on the productidentification, product authentication, and environmental historyinformation; and (d) transmitting by the host server to the imagecapture and communication device an acceptability report.
 28. The methodof claim 25, wherein the non-transitory computer readable storage mediumis one or more non-transitory computer readable storage media, the hostserver is one or more host servers, the image capture and communicationdevice is one or more image capture and communication devices, and theproduct label is one or more product labels.
 29. The method of claim 26,wherein the non-transitory computer readable storage medium is one ormore non-transitory computer readable storage media, the host server isone or more host servers, the image capture and communication device isone or more image capture and communication devices, and the productlabel is one or more product labels.
 30. The method of claim 27, whereinthe non-transitory computer readable storage medium is one or morenon-transitory computer readable storage media, the host server is oneor more host servers, the image capture and communication device is oneor more image capture and communication devices, and the product labelis one or more product labels.
 31. A method comprising: (a) analyzing byan image capture and communication device a product label for a hostproduct, the product label comprising at least two of one or moreenvironmental monitors, one or more authentication elements, and one ormore identification elements; (b) determining by the image capture andcommunication device a type and one or more features based on the typefor each of the at least two of the one or more environmental monitors,one or more authentication elements, and one or more identificationelements; (c) determining by the image capture and communication devicewhether a host server is available; (d) responsive to determining thatthe host server is not available: (d)(i) storing in the image captureand communication device data based on the type and features for each ofthe at least two of the one or more environmental monitors, one or moreauthentication elements, and one or more identification elements;(d)(ii) generating by the image capture and communication device areport indicating whether the host product is acceptable to use based onthe data for the at least two of the one or more environmental monitors,one or more authentication elements, and one or more identificationelements; (e) responsive to determining that the host server isavailable: (e)(i) accessing by the image capture and communicationdevice the host server; (e)(ii) transmitting by the image capture andcommunication device to the host server the data; (e)(iii) receiving bythe image capture and communication device from the host server anacceptability report based on the data for the at least two of the oneor more environmental monitors, one or more authentication elements, andone or more identification elements; and (e)(iv) outputting by the imagecapture and communication device the acceptability report.
 32. Aprogrammed computer system comprising: (a) at least one memory having atleast one region for storing computer executable program code; and (b)at least one processor for executing the program code stored in thememory, wherein the program code, when executed: (b)(i) analyzes aproduct label for a host product, the product label comprising at leasttwo of one or more environmental monitors, one or more authenticationelements, and one or more identification elements; (b)(ii) determines atype and one or more features based on the type for each of the at leasttwo of the one or more environmental monitors, one or moreauthentication elements, and one or more identification elements;(b)(iii) determines whether a host server is available; (b)(iv)responsive to determining that the host server is not available:(b)(iv)(a) stores data in a non-transitory computer-readable storagemedium based on the type and features for each of the at least two ofthe one or more environmental monitors, one or more authenticationelements, and one or more identification elements; (b)(iv)(b) generatesa report indicating whether the host product is acceptable to use basedon the data for the at least two of the one or more environmentalmonitors, one or more authentication elements, and one or moreidentification elements; (b)(v) responsive to determining that the hostserver is available: (b)(v)(a) accesses the host server; (b)(v)(b)transmits to the host server the data; (b)(v)(c) receives from the hostserver an acceptability report based on the data for the at least two ofthe one or more environmental monitors, one or more authenticationelements, and one or more identification elements; and (b)(v)(d) outputsthe acceptability report.